ComatoseNEURO-PULSENCT07506928
NEURO - Prognostication Using Late Somatosensory Evoked - Potentials
A study testing EEGs in people with Comatose and Prognosis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The main aim of this study is to develop a new technique for the passive diagnosis of cognitive-motor dissociation, with the detection of motor intention in a comatose patient by analysing the EEG signal and in particular the ERD/ERS amplitudes in the motor cortex after stimulation of the median nerve. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comatose, Prognosis, Critical Care
- What is being tested?
- EEGs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be aged 18 years or over;
- Patients must be admitted to the intensive care unit with a cerebrovascular pathology;
- Patients must be in a comatose state with a Glasgow score strictly less than 8, 24 hours after stopping sedation.
- Representative of the patient informed of the research and not objecting to it, information and collection of the participant's non-objection if recovery of the ability to understand the content of the information note,
- The patient is a recipient of or affiliated with a social security scheme.
Who cannot join
- Bilateral lesions of the motor cortex or cortico-spinal fasciculus,
- Cutaneous infection of the scalp or any other lesion making surface electroencephalography impossible,
- Patient whose short-term survival (48 - 72 hours) seems compromised,
- Severe peripheral neuromyopathy,
- Severe Acute Respiratory Distress Syndrome at the time of screening,
- Hearing-impaired patients with hearing aids,
- Pregnant or breastfeeding woman,
- Patient under legal protection (persons deprived of their liberty or under guardianship).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Grégoire CANE, MD contact
France1 site
Bordeaux university hospital
Bordeaux, New Aquitaine, 33000
Geoffroy MOUCHEBOEUF, MD, 0557821995 ext. +33, geoffroy.moucheboeuf@chu-bordeaux.fr
Grégoire CANE, MD
About this study
The main aim of this study is to develop a new technique for the passive diagnosis of cognitive-motor dissociation, with the detection of motor intention in a comatose patient by analysing the EEG signal and in particular the ERD/ERS amplitudes in the motor cortex after stimulation of the median nerve.
Read the detailed description
The utilisation of brain-computer interfaces (BCI) employing median nerve stimulation has the potential to yield novel insights into the enhancement of neuroprognostication. The application of painless, low-intensity electrical stimulation to the median nerve has been shown to activate the somatosensory cortex and the motor cortex via cutaneous and proprioceptive afferents. The activation in question has been shown to induce specific modulations of the electroencephalogram (EEG) signal, characterised by event-related desynchronisation (ERD) during stimulation, followed by resynchronisation (ERS) afterwards. The application of this stimulation during a motor task - that is to say, voluntary movement or motor imagery - results in a marked attenuation of post-stimulation ERS, or even its complete absence. The intention to move a hand, when coinciding with median nerve stimulation, amplifies the cortical ERD/ERS signatures, and is made more easily detectable by machine learning algorithms.
The main aim of this study is to develop a new technique for the passive diagnosis of cognitive-motor dissociation, with the detection of motor intention in a comatose patient by analysing the EEG signal and in particular the ERD/ERS amplitudes in the motor cortex after stimulation of the median nerve.
- Conditions
- Comatose, Prognosis, Critical Care
- Being tested
- EEGs
- Keywords
- Prognostication, Somatosensory evoked - potentials, Neurocritical care, Machine learning, Continuous EEG
- Medical subject headings
- Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGsOther
All patients included in the study will receive electroencephalograms (EEGs) of post-stimulation event-related desynchronisation (ERD)/event-related synchronisation (ERS) amplitudes of the median nerve on two occasions per week. These recordings will be made twice a day, once in the morning and once in the afternoon/evening, in order to take account of the patients' inherent nycthemeral rhythm.
A recording of 12 EEG electrodes from the scalp will be made during painless stimulation of the median nerve. The intensity of this stimulation will range from 3 to 14 mA, with a duration of 0.1 ms and a frequency of 5 Hz. This will result in a multiplication of the recording periods during and after stimulation. A final period of approximately 15 minutes of recording will be carried out with headphones on the patient, using simple, pre-recorded, standardized commands. These recordings will be continued for a period of three weeks following their inclusion.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | Patients admitted to the intensive care unit with a cerebrovascular pathology and in a comatose state with a Glasgow score strictly less than 8, 24 hours after stopping sedation. Receives: Other: EEGs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alterations in the electroencephalogram
The alterations in the electroencephalogram (EEG) signal in the event-related desynchronisation/event-related synchronisation cortical signature following median nerve stimulation will be analysed and correlated with the emergence of clinical motor intention.
The detection of cognitive-motor dissociation will rely on classification algorithms that detect the presence of motor activity in EEG signals following median nerve stimulation (MNS). The EEG signals recorded immediately after MNS will be represented as one or more covariance matrices, and several classifiers, including Riemannian classifiers, will then be trained on these matrices to classify a state of rest or motor activity in the EEG.
Measured: 3 weeks after inclusion
CRS-R score
Progression of the Clinical Rating Scale-Revised (CRS-R) score:
Standardized clinical scale assessing level of consciousness across six subdomains: auditory, visual, motor, oromotor/verbal, communication, and arousal.
Total score: 0 to 23
Interpretation:
Lower scores indicate absence or very low levels of consciousness (coma or vegetative state/unresponsive wakefulness syndrome).
Intermediate scores indicate minimal but definite behavioral evidence of consciousness (minimally conscious state).
Higher scores indicate more complex behaviors consistent with a higher level of consciousness (emergence from the minimally conscious state).
Measured: 3 weeks after inclusion
Glasgow score
Glasgow Coma Scale (GCS) Standardized clinical scale assessing level of consciousness based on three components: eye opening, verbal response, and motor response.
Total score: 3 to 15
Interpretation:
Lower scores indicate severe impairment of consciousness (coma or deep unconsciousness).
Intermediate scores indicate moderate impairment of consciousness. Higher scores indicate mild or no impairment of consciousness.
Measured: 3 weeks after inclusion
Secondary outcomes (2)
GOS-E
The functional neurological prognosis in the period subsequent to the event will be evaluated by the Glasgow Outcome Scale-Extended (GOS-E) Standardized clinical scale assessing functional outcome and disability following brain injury, based on overall level of independence and social functioning.
Total score: 1 to 8
Interpretation:
Lower scores indicate severe disability or death. Intermediate scores indicate moderate disability with some level of independence.
Higher scores indicate good recovery with return to independent functioning.
Measured: 6 months after inclusion
SF36
The functional neurological prognosis in the period subsequent to the event will be evaluated by the Short Form-36 Health Survey (SF-36) Standardized patient-reported outcome measure assessing health-related quality of life across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems, and mental health.
Score range: 0 to 100 for each domain (and summary scores)
Interpretation:
Lower scores indicate poorer health-related quality of life. Higher scores indicate better health-related quality of life.
Measured: 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start30 Jun 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComatoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This prospective interventional study involves the use of passive somaesthetic stimulation, which is defined as painless electrical stimulation of the median nerve, in conjunction with electroencephalogram (EEG) recordings. The study is being conducted in a single centre, specifically the neuro-resuscitation department of the Pellegrin Hospital in Bordeaux
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Inria, the French National Institute for computer science and applied mathematics
- Responsible party
- Sponsor
- Investigators
- Geoffroy MOUCHEBOEUF, MD, Principal investigator, University Hospital, BordeauxGrégoire CANE, MD, Study director, University Hospital, BordeauxFabien LOTTE, Study chair, Institut National de Recherche en Informatique et en Automatique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506928
- Sponsor's protocol ID
- CHUBX 2025/053
- Acronym
- NEURO-PULSE
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEURO - Prognostication Using Late Somatosensory Evoked - Potentials
- ClinicalTrials.gov ID
- NCT07506928
- Acronym / sponsor ID
- NEURO-PULSE / CHUBX 2025/053
- Conditions
- Comatose, Prognosis, Critical Care
- Keywords
- Prognostication, Somatosensory evoked - potentials, Neurocritical care, Machine learning, Continuous EEG
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Inria, the French National Institute for computer science and applied mathematics
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to develop a new technique for the passive diagnosis of cognitive-motor dissociation, with the detection of motor intention in a comatose patient by analysing the EEG signal and in particular the ERD/ERS amplitudes in the motor cortex after stimulation of the median nerve.
Detailed description
The utilisation of brain-computer interfaces (BCI) employing median nerve stimulation has the potential to yield novel insights into the enhancement of neuroprognostication. The application of painless, low-intensity electrical stimulation to the median nerve has been shown to activate the somatosensory cortex and the motor cortex via cutaneous and proprioceptive afferents. The activation in question has been shown to induce specific modulations of the electroencephalogram (EEG) signal, characterised by event-related desynchronisation (ERD) during stimulation, followed by resynchronisation (ERS) afterwards. The application of this stimulation during a motor task - that is to say, voluntary movement or motor imagery - results in a marked attenuation of post-stimulation ERS, or even its complete absence. The intention to move a hand, when coinciding with median nerve stimulation, amplifies the cortical ERD/ERS signatures, and is made more easily detectable by machine learning algorithms.
The main aim of this study is to develop a new technique for the passive diagnosis of cognitive-motor dissociation, with the detection of motor intention in a comatose patient by analysing the EEG signal and in particular the ERD/ERS amplitudes in the motor cortex after stimulation of the median nerve.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This prospective interventional study involves the use of passive somaesthetic stimulation, which is defined as painless electrical stimulation of the median nerve, in conjunction with electroencephalogram (EEG) recordings. The study is being conducted in a single centre, specifically the neuro-resuscitation department of the Pellegrin Hospital in Bordeaux
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Other: EEGsPatients admitted to the intensive care unit with a cerebrovascular pathology and in a comatose state with a Glasgow score strictly less than 8, 24 hours after stopping sedation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must be aged 18 years or over;
- Patients must be admitted to the intensive care unit with a cerebrovascular pathology;
- Patients must be in a comatose state with a Glasgow score strictly less than 8, 24 hours after stopping sedation.
- Representative of the patient informed of the research and not objecting to it, information and collection of the participant's non-objection if recovery of the ability to understand the content of the information note,
- The patient is a recipient of or affiliated with a social security scheme.
Key exclusion criteria (8 listed)
- Bilateral lesions of the motor cortex or cortico-spinal fasciculus,
- Cutaneous infection of the scalp or any other lesion making surface electroencephalography impossible,
- Patient whose short-term survival (48 - 72 hours) seems compromised,
- Severe peripheral neuromyopathy,
- Severe Acute Respiratory Distress Syndrome at the time of screening,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEGsAll patients included in the study will receive electroencephalograms (EEGs) of post-stimulation event-related desynchronisation (ERD)/event-related synchronisation (ERS) amplitudes of the median nerve on two occasions per week. These recordings will be made twice a day, once in the morning and once in the afternoon/evening, in order to take account of the patients' inherent nycthemeral rhythm. A recording of 12 EEG electrodes from the scalp will be made during painless stimulation of the median nerve. The intensity of this stimulation will range from 3 to 14 mA, with a duration of 0.1 ms and a frequency of 5 Hz. This will result in a multiplication of the recording periods during and after stimulation. A final period of approximately 15 minutes of recording will be carried out with headphones on the patient, using simple, pre-recorded, standardized commands. These recordings will be continued for a period of three weeks following their inclusion. | Other | Patient |
Primary outcome
Alterations in the electroencephalogram
Time frame: 3 weeks after inclusion
The alterations in the electroencephalogram (EEG) signal in the event-related desynchronisation/event-related synchronisation cortical signature following median nerve stimulation will be analysed and correlated with the emergence of clinical motor intention. The detection of cognitive-motor dissociation will rely on classification algorithms that detect the presence of motor activity in EEG signals following median nerve stimulation (MNS). The EEG signals recorded immediately after MNS will be represented as one or more covariance matrices, and several classifiers, including Riemannian classifiers, will then be trained on these matrices to classify a state of rest or motor activity in the EEG.
CRS-R score
Time frame: 3 weeks after inclusion
Progression of the Clinical Rating Scale-Revised (CRS-R) score: Standardized clinical scale assessing level of consciousness across six subdomains: auditory, visual, motor, oromotor/verbal, communication, and arousal. Total score: 0 to 23 Interpretation: Lower scores indicate absence or very low levels of consciousness (coma or vegetative state/unresponsive wakefulness syndrome). Intermediate scores indicate minimal but definite behavioral evidence of consciousness (minimally conscious state). Higher scores indicate more complex behaviors consistent with a higher level of consciousness (emergence from the minimally conscious state).
Glasgow score
Time frame: 3 weeks after inclusion
Glasgow Coma Scale (GCS) Standardized clinical scale assessing level of consciousness based on three components: eye opening, verbal response, and motor response. Total score: 3 to 15 Interpretation: Lower scores indicate severe impairment of consciousness (coma or deep unconsciousness). Intermediate scores indicate moderate impairment of consciousness. Higher scores indicate mild or no impairment of consciousness.
2 secondary outcomes
GOS-E
Time frame: 6 months after inclusion
SF36
Time frame: 6 months after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grégoire CANE, MD contact
Geoffroy MOUCHEBOEUF, MD principal investigator
University Hospital, Bordeaux
Grégoire CANE, MD study director
University Hospital, Bordeaux
Fabien LOTTE study chair
Institut National de Recherche en Informatique et en Automatique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEGs in people with Comatose and Prognosis, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geoffroy MOUCHEBOEUF, MD (05 57 82 19 95 ext. +33, geoffroy.moucheboeuf@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alterations in the electroencephalogram (time frame: 3 weeks after inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.